RFP - 36C26222R0151 Cardiovascular Perfusionist Services VASDHS.docx

36C26222R0151

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

09-09-2022 Tashodra Rogers, Contracting Officer

09-30-2022

3:00 PM

PDT

36C262 Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

X

541990 $16.5 Million

N/A

36C664 Department of Veterans Affairs San Diego Healthcare System 3350 La Jolla Village Drive

San Diego CA 92161 36C262 Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin, TX 78714-9971 http://www.tungsten-network.com/ 1-877-353-9791

See CONTINUATION Page

The Department of Veterans Affairs San Diego Healthcare System requires On-Site Board Certified Cardiovascular Perfusionist Services on an "as-needed basis".

Please see schedule of services on pages: 5-7

Please see the Performance Work Statement on pages: 8-35

See CONTINUATION Page

Tashodra Rogers Contracting Officer

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

· Tungsten e-Invoice Setup Information: 1-877-489-6135

· Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

· FSC e-Invoice Contact Information: 1-877-353-9791

· FSC e-Invoice email: vafsccshd@va.gov

5. POST AWARD ORIENTATION – The Contracting Officer will schedule a post award orientation for contract orientation purposes as required by VA Acquisition Manual, Part M842.502-70 https://www.va.gov/oal/library/vaam/vaamM842.asp#M84250270

6. ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 SCHEDULE OF SERVICES AND PRICE

The Contractor shall furnish all personnel to provide services necessary to perform onsite Certified Cardiovascular Perfusionist Services to eligible beneficiaries of the Department of Veterans Affairs Medical Center, San Diego (hereinafter referred to as VAMC). The Contractor’s physician(s) care shall cover the range of Certified Cardiovascular Perfusionist Services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by the American Board of Cardiovascular Perfusion http://www.abcp.org Place of Performance: Services shall be provided on site, VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161 Orders: Orders shall be placed against this (FFP-IDIQ) contract at the time of contract award, and as needed during the term of the contract. Task Orders shall specify the estimated quantities of services for the period of performance and shall comply with FAR 52.216-18 and 52.216-19.

Ordering Procedures: Individual task orders will be based on the clinical coverage required for the defined period of performance for the task order. Task orders will be funded annually by the Contracting Officer and issued to the contractor. The guaranteed minimum for the initial fiscal year in which this contract is awarded is $500.00. The maximum total value of the contract, inclusive of the base year and all options exercised, shall not exceed $3,000,000.00. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

The previous option year pricing will apply to any extension pursuant to FAR 52.217-8.

Estimated Period of Performance: BASE YEAR: December 1, 2022, to November 30, 2023

Annual Cost

Hours

Hours

Total for Base Year $___________________________________________

Estimated Option Year One (1): December 1, 2023 – November 30, 2024

Annual Cost

Hours

On Call Services

Total for Option Year 1 $___________________________________________ Estimated Option Year Two (2): December 1, 2024 – November 30, 2025

Annual Cost

Hours

Hours

On Call Services

Total for Option Year 2 $___________________________________________ Estimated Option Year Three (3): December 1, 2025 – November 30, 2026

Annual Cost

Hours

Hours

On Call Services

Total for Option Year 3 $___________________________________________ Estimated Option Year Four (4): December 1, 2026 – November 30, 2027

Annual Cost

Hours

On Call Services

Total for Option Year 4 $___________________________________________

Base Year: _____________________________ Option Year One (1): ____________________ Option Year Two (2): ____________________ Option Year Three (3): ___________________ Option Year Four (4): ____________________ Total For Base and All Option Years: __________________________

Page 1 of Page 1 of

B.3 PERFORMANCE WORK STATEMENT

1. GENERAL:

1.1. Services Provided: The Contractor shall provide Board Certified Cardiovascular Perfusionist Service on site in accordance with the terms and conditions contained herein to beneficiaries of the Department of Veterans Affairs (VA), San Diego Healthcare System.

1.2. Place of Performance - Contractor shall furnish services at the VA San Diego Healthcare System (VASDHS), 3350 La Jolla Village Drive, San Diego, CA 92161

1.3. Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority; FAR Parts 12 In combination with FAR Part 15.

1.4. Policy/Handbooks - The contractor shall be subject to the following policies, including any subsequent updates during the period of performance:

1.4.1. VHA Handbook 1100.17: National Practitioner Data Bank Reports https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

1.4.2. VHA Handbook 1100.18: Reporting And Responding To State Licensing Boards https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9174

1.4.3. VHA Handbook 1100.19: Credentialing and Privileging https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

1.4.4. VHA Directive 1192: Seasonal Influenza Prevention Program https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5472

1.4.5. VHA Directive 1220: Facility Procedure Complexity Designation Requirements to Perform Invasive Procedures In Any Clinical Setting https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8365

1.4.6. VA Directive 1663: Health Care Resources Contracting - Buying https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

1.4.7. VHA Handbook 1907.01: VHA Health Information Management and Health Records https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235

1.4.8. Privacy Act of 1974 (5 U.S.C. 552a) as amended http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.4.9. Joint Commission –

http://www.jointcommission.org/standards/

1.4.10. HHS OIG Website –

http://oig.hhs.gov/exclusions/index.asp

1.4.11. American Journal for Infection Control - AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

1.5. Definitions/Acronyms: Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

1.5.1. ABCP American Board of Cardiovascular Perfusion

1.5.2. ACGME: Accreditation Council for Graduate Medical Education

1.5.3. ACLS: Advanced Cardiac Life Support

1.5.4. BLS: Basic Life Support

1.5.5. CDC: Centers for Disease Control and Prevention

1.5.6. CDR: Contract Discrepancy Report

1.5.7. CEU: Certified Education Unit

1.5.8. CME: Continuing Medical Education

1.5.9. CMP: Civil Monetary Penalty

1.5.10. CMS: Centers for Medicare and Medicaid Services

1.5.11. CO: Contracting Officer – The person executing this contract on behalf of the Government with the authority to enter into and administer contracts and make related determinations and findings.

1.5.12. COR: Contracting Officer’s Representative – A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

1.5.13. COS: Chief of Staff

1.5.14. COVID-19: Coronavirus Disease 2019

1.5.15. CPARS: Contractor Performance Assessment Reporting System

1.5.16. DEA: Drug Enforcement Agency

1.5.17. ED: Emergency Department

1.5.18. ECMO: Extracorporeal Membrane Oxygenation

1.5.19. EHR: Electronic Health Record - electronic health record system used by the VA

1.5.20. EMR: Electronic Medical Record

1.5.21. FSMB: Federation of State Medical Boards

1.5.22. FTEE: Full Time Equivalency Employee is defined by VA as a minimum of 80 hours every two weeks and does not include holidays

1.5.23. HHS: Department of Health and Human Services

1.5.24. HIPAA: Health Insurance Portability and Accountability Act

1.5.25. HR: Human Resources

1.5.26. ISO: Information Security Officer

1.5.27. National Provider Identifier (NPI): NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers).

1.5.28. NLNAC: National League for Nursing Accrediting Commission. www.nlnac.org

1.5.29. Non-Contract Provider - any person, organization, agency, or entity that is not directly or indirectly employed by the Contractor or any of its subcontractors.

1.5.30. NP: Nurse Practitioner

1.5.31. NPPES: National Plan and Provider Enumeration System

1.5.32. OSHA: Occupational Safety and Health Administration

1.5.33. OIT: Office of Information and Technology

1.5.34. OPM: Office of Personnel Management

1.5.35. OPPE: Ongoing Provider Practice Evaluation

1.5.36. OR: Operating Room

1.5.37. PA: Physician Assistant

1.5.38. PIV: Personal Identity Verification

1.5.39. POP: Period of Performance

1.5.40. PPD: Purified Protein Derivative

1.5.41. PWS: Performance Work Statement

1.5.42. QASP: Quality Assurance Surveillance Plan

1.5.43. RFP: Request for Proposal

1.5.44. VAMC: Veterans Affairs Medical Center

1.5.45. Veterans Health Administration (VHA): The central office for administration of the VA medical centers throughout the United States. The VHA is in Washington, D.C.

1.5.46. Veterans Integrated Services Network (VISN): The regional oversight for the VA medical centers.

1.5.47. VISTA (Veterans Integrated Systems Technology Architecture): A PC based system that will capture and store clinical imagery, scanned documents and other non-textual data files and integrates them into patient’s medical record and with the hospital information system.

1.5.48. VetPro: a federal web-based credentialing program for healthcare providers.

1.5.49. Veterans Affairs Medical Center (VAMC): Unless identified with the name of a different VA Medical Center, for the purpose of this contract, this term shall mean the San Diego VA Medical Center.

2. QUALIFICATIONS:

2.1. Staff/Facility – The contractor shall provide 1.0 Full Time Equivalency Employees (FTEEs), consisting of 2 Board Certified Cardiovascular Perfusionists located at the San Diego VA Medical Center.

2.1.1. License - All licenses held by the personnel working on this contract shall be full and unrestricted license to the services covered by this contract issued in any State, Territory, or Commonwealth of the United States or the District of Columbia. Contract personnel shall submit evidence of current, full and unrestricted licenses, registration, certification, and/or other relevant credentials for verification prior to appointment and throughout the employment process, as requested by the COR. Contractor is responsible for keeping the COR informed of anything that would adversely affect or otherwise limit their clinical privileges. Failure to meet this requirement may result in termination of the contract.

2.1.2. Board Certification – The contractor’s employees and any subcontractors shall have all licenses, permits, and certifications as required by law and this contract. All Cardiovascular Perfusionists shall be certified with at least a minimum of ten (10) years of experience. All Perfusionists shall be a graduate of an accredited Allied Health Education Program School of Perfusion Technology and shall be certified by the American Board of Cardiovascular Perfusion, demonstrate evidence of meeting continuing education requirements and shall have performed a minimum of 1000 clinical cases. Experience shall be demonstrated in the following areas: Experience shall be demonstrated in the following areas: open heart surgery with use of Sorin cardiopulmonary bypass machine, autotransfusion, Sorin cell salvage equipment, membrane oxygenation, left/right heart bypass, intra-aortic balloon pump.

2.1.2.1. All continuing education courses required for maintaining certification must always be kept up to date. Documentation verifying current certification shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance. A folder with the stated qualifications will be maintained by the COR.

2.1.3. Credentialing and Privileging - Contract Perfusionist fulfilling the conditions of the contract shall be subject to all bylaws, rules and regulations of the VAMC. Each Perfusionist shall be credentialed and privileged prior to providing services and must be found acceptable by the Medical Executive committee and Governing Body. Credentialing and privileging is to be completed in accordance with VHA Handbook 1100.19 referenced above. The ability for an individual Perfusionist to continue to render services under the contract shall be dependent upon demonstration of clinical competence. Clinical competency shall be assessed on an ongoing basis, is true for all Perfusionist and to the reported as provider specific practice information at the time or an accreditation body with equal or better standards Joint Commission.

2.1.3.1. If a contract personnel (s) is not credentialed and privileged or has credentials/privileges suspended or revoked, the Contractor shall furnish an acceptable substitute without any additional cost to the government.

2.1.4. Technical Proficiency - Contract personnel (s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all contract personnel(s) and contract personnel (s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

2.1.5. Continuing Medical Education (CME)/ Certified Education Unit (CEU) Requirements: Contractor shall provide the COR copies of current CMEs as required or requested by the VAMC. Contract personnel (s) registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. Contractor shall report CME hours to the credentials office for tracking. These documents are required for both privileging and re-privileging. Failure to provide shall result in loss of privileges for contract personnel (s).

2.1.6. Training (ACLS, BLS, EHR and VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the contractor’s physician(s) as required by the VA. Other training may become required. VA will communicate any changes to the training requirement to the contractor.

2.1.7. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for physicians within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year.

2.1.7.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s physician (s) {This is applicable to all health care workers}. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results.

2.1.7.2. MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor physicians {This is applicable to all health care workers}.

2.1.7.3. VARICELLA: Contractors shall provide proof of immunity for all Contractor physicians {This is applicable to all health care workers}.

2.1.7.4. ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor physicians {This is applicable to all health care workers}.

2.1.7.5. INFLUENZA: Contractors shall provide proof that all Contractor physicians have received the annual Influenza vaccine unless it is contraindicated. If the Contractor physician has a medical contraindication to the vaccine they shall be required to wear a mask during the Influenza season. {This is applicable to all health care workers}.

2.1.7.6. COVID-19: Contractors shall comply with VHA Supplemental Contract Requirements for Combatting COVID-19 {This is applicable to all health care workers}. See Section D attachment.

2.1.7.7. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor’s physician (s) {This is applicable to all health care workers}; provide their own Hepatitis B vaccination series and hepatitis B surface antigen test results following the hepatitis B vaccination series; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

2.1.7.8. The VAMC shall notify the Contractor of any significant communicable disease exposures as appropriate. Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in health care personnel ( as published in American Journal for Infection Control- AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf) for disease control. Contractor shall provide follow up documentation of clearance to return to the workplace prior to their return.

2.1.8. National Provider Identification (NPI): NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers). The Contractor shall have or obtain appropriate NPI and if pertinent the Taxonomy Code confirmation notice issued by the Centers for Medicare and Medicaid Services (CMS) National Plan and Provider Enumeration System (NPPES) be provided to the Contracting Officer with the proposal.

2.1.9. Conflict of Interest: The Contractor and all contract personnel (s) are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest (Jan 2008) and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.1.10. Citizenship related Requirements:

2.1.10.1. The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals;

2.1.10.2. While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order 12989” and any related pertinent Amendments, as well as applicable Federal Acquisition Regulations.

2.1.10.3. If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach.

2.1.10.4. This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

2.1.10.5. The Contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offerors response to the RFP using the subject attachment in Section D of the solicitation document.

2.1.11. Annual Office of Inspector General (OIG) Statement: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

2.1.11.1. Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site referenced above to ensure that the proposed contract physician (s) are not listed. Contractor should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMP’s may also be imposed against the Contractor that employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

2.1.11.2. By submitting their proposal, the Contractor certifies that the HHS OIG List of Excluded Individuals/Entities has been reviewed and that the Contractors are and/or firm is not listed as of the date the offer/bid was signed.

2.2. Clinical/Professional Performance: The qualifications of Contractor personnel are subject to review by VA Medical Center COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Handbook 1100.19. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the VAMC COS and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

2.3. Non- Personal Healthcare Services: The parties agree that the Contractor and all contract personnel (s) shall not be considered VA employees for any purpose.

2.4. Indemnification: The Contractor shall be liable for, and shall indemnify and hold harmless the Government against, all actions or claims for loss of or damage to property or the injury or death of persons, arising out of or resulting from the fault, negligence, or act or omission of the Contractor, its agents, or employees.

2.5. Prohibition Against Self-Referral: Contractor’s physicians are prohibited from referring VA patients to contractor’s or their own practice(s).

2.6. Inherent Government Functions: Contractor and Contract personnel (s) shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees (outside a clinical context), selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

2.7. No Employee status: The Contractor shall be responsible for protecting Contract personnel (s) furnishing services. To carry out this responsibility, the Contractor shall provide or certify that the following is provided for all their staff providing services under the resultant contract:

2.7.1. Workers’ compensation

2.7.2. Professional liability insurance

2.7.3. Health examinations to include:

2.7.4. Annual TB Skin Test and recent chest X-Ray if there is a history of positive TB skin test

2.7.5. Evidence of Hepatitis B immunity (hepatitis immune titer, if the individual has had the series of shots; if no immunity, evidence that the individual has started the Hepatitis B vaccination series

2.7.6. Evidence of a Hepatitis C titer

2.7.7. Varicella titer if contracted employee has not had chicken pox

2.7.8. Income tax withholding, and

2.7.9. Social security payments

2.8. Tort Liability: The Federal Tort Claims Act does not cover Contractor or contract personnel (s). When a Contractor or contract personnel (s) has been identified as a provider in a tort claim, the Contractor shall be responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s (or contract provider (s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.9. Key Personnel:

2.9.1. The VA Full Time Equivalency (FTE): FTE is defined by VA as a minimum of 80 hours every two weeks and does not include holidays.

2.9.2. The number of Board Certified Perfusionists required to be on site daily as needed as defined in paragraph Hours of Operation of this section.

2.9.3. The Contractor shall be responsible for providing coverage to the VA during periods of vacancies of the Contractor’s personnel due to sick leave, personal leave, vacations and additional coverage as required. In the event a scheduled provider is unable to complete an assigned shift, the contractor shall provide replacement provider coverage within 2 hours and notify the Contracting Office Representative (COR) at the (San Diego VA Medical Center) immediately of the schedule change.

2.10. Personnel Substitutions: During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death or termination of employment. The Contractor shall notify the CO, in writing, within 15 calendar days after the occurrence of any of these events and provide the information required below. After 90 days, the Contractor shall submit the information required below to the CO at least 15 calendar days prior to making any permanent substitutions.

2.10.1. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the CO. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The CO will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

2.10.2. For temporary substitutions where the key person shall not be reporting to work for three (3) consecutive workdays or more, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

2.10.3. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. Should the VA COS or designee show documented clinical problems or continual unprofessional behavior/actions with any contract personnel (s), s/he may request, without cause, immediate replacement of said contract personnel (s).

2.10.4. The CO and COR shall deal with issues raised concerning Contract personnel (s) conduct. The final arbiter on questions of acceptability is the CO.

2.10.5. Contingency Plan: Because continuity of care is an essential part of VAMC’s medical services, The Contractor shall have a contingency plan in place to be utilized if the contract personnel (s) leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

2.10.6. Note: Evidence of completion of required licensure, credentials, required training, current competencies and background investigations must be validated for all contractor personnel referred to perform services under this contract prior to providing direct patient care. Contractor shall not have any personnel report to duty until written notification is received from the Contracting Officer advising that the candidate (s) presented has met all requirements for contract performance.

3. HOURS OF OPERATION:

3.1. VA Business Hours: VA business hours/hours of operation are 7:00am through 4:30pm.

3.1.1. Work Schedule: Scheduling of services shall be on-call basis as needed. There are no minimum number of hours guaranteed. Contractor shall be available to provide Board Certified Cardiovascular Perfusionist coverage 365/366 days a year.

3.1.2. The perfusionist shall be available twenty-four (24) hours a day, seven (7) days a week, including all national holidays.

3.1.3. The perfusionist shall be on site to set up heart lung machine within one (1) hours of notification of need for services.

3.2. Federal Holidays:

· New Year’s Day

· Martin Luther King’s Birthday

· President’s Day

· Memorial Day

· Juneteenth

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving Day

· Christmas Day

· Any day specifically declared to be a national holiday

4. CONTRACTOR RESPONSIBILITIES:

4.1. Clinical Personnel Required: The Contractor shall provide contract personnel (s) who are competent, qualified per this performance work statement and adequately trained to perform assigned duties.

4.1.1. Contract personnel (s) shall be responsible for signing in and out when in attendance. Time sheets will be used by the COR to confirm hours/day and services provided against the contractor’s invoices.

4.2. Standards of Care: The contract personnel (s)’ care shall cover the range of Perfusionist/Autotransfusion services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by:

4.2.1. American Board of Cardiovascular Perfusion: http://www.abcp.org

4.2.3. The professional standards of The Joint Commission (TJC) http://www.jointcommission.org/standards_information/standards.aspx

4.2.4. The standards of the American Hospital Association (AHA) http://www.hpoe.org/resources?show=100&type=8 and;

4.2.5. The requirements contained in this PWS

4.3. MEDICAL RECORDS

4.3.1. Authorities: Contract personnel (s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

4.3.2. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. Treatment and administrative patient records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’ (24VA10P2). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at his expense. Contractor shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date.

4.3.3. Disclosure: Contract personnel (s) may have access to patient medical records: however, Contractor shall obtain permission from the VA before disclosing any patient information. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records. The VA will provide the Contractor with a copy of VHA Handbook 1907.01, Health Information Management and Health Records and VHA Directive 1605.01, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

4.3.4. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Handbook 1907.01 Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235 and all guidelines provided by the VAMC.

4.3.5. Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. Contractor will not release or disclose copies of records and will refer all such requests to the Release of Information Department at the VA facility where assigned.

4.3.6. Management for Medical Record: National Archives and Records Administration record disposition requirements are found in RCS 10-1 Chapter 6, 6000 series.

4.3.7. Confidentiality - VA will provide the contract personnel (s) access to pertinent patient medical information, within the existing privacy rules and regulations, for the purpose of providing coordinated comprehensive primary care. Contract personnel (s) shall ensure the confidentiality of all patient information and shall be held liable in the event of the breach of confidentiality.

4.3.8. Personal Identity Verification (PIV) - Contract personnel (s) shall participate in computer security and documentation training as is all personnel practicing within the VA Medical Center. Contract personnel (s) shall comply with facility requirements to obtain personal security investigations, installation access and participate in the computer security and documentation training.

4.3.9. Contract personnel (s) shall provide medical record documentation in accordance with rules and regulations of the medical staff and medical staff by laws. Reference Policy Memorandum No. 136-1, Change 2 to Appendix B dated Sept. 29, 2000, Control of Medical Records and in accordance with Policy Memorandum 136-1, Change 2 to Appendix A dated September 29, 2000, Completion of Medical Records.

4.3.10. Records created by contract personnel (s) in the course of treating VA patients under this agreement are the property of the VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations. Contract personnel (s) shall maintain computer access and prepare for cases the following day by obtaining the patient information and record within the current electronic health record system for review.

4.3.11. Contract personnel (s) shall participate in quality improvement projects, initiatives, and reporting as requested.

4.3.11.1. VA utilizes a fully automated electronic medical record. The EMR consists of two primary components. The first is the Veterans Health Information System and Technology Architecture (VISTA), which consists of commercial hardware and software developed by the VA. VISTA is a collection of over 100 applications that make up a comprehensive hospital information system. It includes both medical records and clinical applications or packages such as order entry, progress note, laboratory, radiology, and scheduling/admission-discharge-transfer and discharge summary. The present VISTA packages combined comprise an estimated 80 percent of the information maintained in the EMR. Contract personnel (s) shall be responsible for viewing the patient record within the EHR and will not be utilizing the VISTA system.

4.3.11.2. Upon transfusion of components, the Perfusionists are responsible for completing the required information on the SF-518 form (Record of Transfusion on the Standard Form 518) to include pre-transfusion data and post-transfusion data. The completed original SF-518 shall be scanned into the patient's chart, and a copy of the SF-518 shall be placed in the designated location for return to the Blood Bank. Under no circumstances will the SF-518 be discarded.

4.3.11.3. The second component uses optical disk imaging technology to meet the remaining 20 percent of the EMR information needs such as advance directive/guardianship papers, medical record documentation from non-VA facilities and informed consents.

4.3.11.4. VA will provide the necessary training to contract personnel (s) on the proper use and operation of the current computerized medical records system (Electronic Health Record - EHR). Contractor agrees and shall instruct their employees in signing computer security access agreements and is bound by confidentiality and release of information restrictions. For purposes of clarity, where the VA Forms reference “Contracted Employee Name” it shall mean “Contractor’s Employee Name.”

4.4. Direct Patient Care: 95% of the time involved in direct patient care. The Perfusionist role will be 95% to patient care related.

4.4.1. Scope of Care: Contract personnel (s) (as appropriate and within scope of practice/privileging) shall be responsible for providing Perfusion/Autotransfusion care, including, but not limited to:

4.4.1.1 Contractor shall provide perfusion services during open heart surgery, service for take back and angioplasties, intra-aortic balloon pump and left ventricular assist device set up and monitoring and cell save set up and operation. The Perfusionist is required to operate machinery that continues to pump oxygenated blood through the patient during open-heart surgical procedures. The clinical perfusionist shall as required, administer medications, such as blood products during surgery.

4.4.1.2 The Perfusionist shall be well versed by virtue of training and experience in all aspects of clinical perfusion. This includes experience utilizing standard cardiopulmonary bypass equipment preference shall be given for experience in the utilization of SORIN© equipment which is currently utilized at this facility), with the ability to use Computerized Patient Record System (CPRS) (preference shall be given for experience in the utilization of CPRS) and integrate with the SORIN© Data Management System, standard membrane and non-membrane oxygenerator systems, blood and red cell salvaging equipment ( preference shall be given for experience in the use of the SORIN© Cell Saver Systems), pulsatile preservation routines, intra-aortic balloon pumps and a research or clinical experience in other forms of assisted circulation.